Objective: To demonstrate the mass gathering hajj medication safety as new initiatives in the Kingdom of Saudi Arabia. Methods: It is a new initiative project drove by national mass gathering pharmaceutical programs. The projects drove the mass gathering medicine guidelines and the international business model, pharmacy project guidelines project management institution guidelines of a new project. The initiative project is written through project management professionals and consisted of several parts, including the initial phase, the planning phase, the execution phase and the monitoring and controlling phase. Results: The medication safety services during the mass gathering with a defined vision, mission and goals. The services had multiple benefits, including clinical and economical on patients and healthcare services, as described in the review. The extension of the project assured by risk management elements description. Besides, the monitoring and controlling of the services as illustrated. The conversion of operation project, though closing project stage illustrated in the analysis. Conclusion: The mass gathering medication safety is a new initiative project that is part of the mass gathering medicine. There is various part of medication safety services can be started during the mass gathering; it is highly recommended in Saudi Arabia.